步長製藥(603858.SH):小兒敷臍止瀉散上市許可持有人變更為陝西步長的申請獲批
格隆匯3月23日丨步長製藥(603858.SH)公佈,公司全資子公司陝西步長製藥有限公司(簡稱“陝西步長”)近日收到國家藥品監督管理局核准簽發的關於小兒敷臍止瀉散的《藥品補充申請批准通知書》。
申請內容:小兒敷臍止瀉散(批准文號:國藥準字Z10940024)的上市許可持有人由“安陽諾美藥業有限公司”變更為“陝西步長製藥有限公司”,生產企業及生產地址不變。
小兒敷臍止瀉散功能主治:温中散寒,止瀉。主治小兒中寒、腹瀉、腹痛。小兒敷臍止瀉散是已有生產批文的獨家中藥上市產品,陝西步長是該產品的唯一所有權者。
藥品市場銷售情況:根據米內網數據查詢,小兒敷臍止瀉2018年至2020年中國城市零售藥店銷售額依次為23萬元、16萬元、5萬元。
同類藥品市場銷售情況:經米內網數據查詢,現市場同類藥品主要為丁桂兒臍貼,2018年至2020年中國城市零售藥店銷售額依次為41,647萬元、41,909萬元、29,697萬元。
截至公吿披露日,公司在小兒敷臍止瀉散產品上投入的費用約為570萬元人民幣。
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